BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUIOS CL FLOW CYTOMETER

    MDR report key: 7046836 · Received November 20, 2017

    Report

    Report Number
    1061932-2017-00020
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    November 4, 2017
    Report Date
    November 6, 2017
    Manufacturer
    BECKMAN COULTER IRELAND INC.
    Product Code
    OYE
    UDI-DI
    15099590225889
    PMA / PMN Number
    K141932
    Removal / Correction Number
    2050012-0928/2017-022C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: CORRECTION/REMOVAL REPORTING NUMBER UPDATED TO REFLECT CORRECT NUMBER.

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER SOFTWARE ENGINEER ARRIVED AT THE CUSTOMER SITE ON 15-NOV-2017. THE CUSTOMER'S DATABASE WAS RETRIEVED AND ANALYZED FOR DATA FROM THE DATE OF EVENT TO PRESENT. INITIAL ANALYSIS ON SITE SHOWED THAT THERE WERE DUPLICATE SAMPLE ID EVENTS ON (B)(6) 2017. ADDITIONAL ANALYSIS PERFORMED BY SOFTWARE ENGINEERS ON 16-NOV-2017 IDENTIFIED SEVENTEEN (17) MIS-IDENTIFIED SAMPLES AND ELEVEN (11) SUSPICIOUS SAMPLES. FURTHER ANALYSIS AND INVESTIGATION OF THE ENTIRE DATABASE IS ONGOING. THE CUSTOMER HAS TURNED OFF THE AUTO-RELEASE FEATURE AND IS REVIEWING EACH RESULT BEFORE RELEASING IT TO THE LABORATORY INFORMATION SYSTEM (LIS). BASED ON THE INFORMATION AVAILABLE, THE ASSIGNABLE CAUSE IS AN AQUIOS CL SOFTWARE MALFUNCTION. THE RECALL (FA-31978) WHICH INCLUDED NOTIFICATION TO THE CUSTOMER AND INSPECTION OF CUSTOMERS' DEVICE DATA WILL BE UPDATED VIA ADDITIONAL COMMUNICATION TO CUSTOMERS TO ADDRESS THIS NEW FAILURE MODE. UPDATED RECALL TO BE INITIATED THE WEEK OF 27-NOV-2017. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEEING A RECURRENCE OF A PREVIOUSLY REPORTED EVENT CONSISTING OF PATIENT SAMPLES BEING RERUN WITHOUT BEING PROMPTED ON THE AQUIOS CL INSTRUMENT. THE CUSTOMER ALLEGED THAT 5 SAMPLE IDS HAD BEEN 'REUSED'. THIS REPORT (1061932-2017-00020) REFERS TO THE EVENT THAT TOOK PLACE ON THE DATE OF EVENT. RELATED REPORT 1061932-2017-00017 REFERS TO THE EVENT THAT TOOK PLACE (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825076 AQUIOS CL FLOW CYTOMETER FLOW CYTOMETER OYE BECKMAN COULTER IRELAND INC. B30166 NA 15099590225889

    Patients

    Seq Age Sex Outcome Treatment
    1